INT LEGEND COMBO 4C
Received Sep 30, 2011 · Event occurred Jan 31, 2011
Report 9616086-2011-00121 · MDR key 2275973
Device
Product problems
- Thermal Decomposition of Device
- Device Emits Odor
- Inappropriate/Inadequate Shock/Stimulation
Patient
Not reported
- Pain
- Electric Shock
Narrative
Description of Event or Problem
REPORTED THAT DURING TREATMENT WITH ESTIM OPERATION ON CH 3 AND 4 ON IFC, UNIT SHOCKED A PATIENT WHILE IN USE. THE PATIENT REPORTED EXTREME PAIN. IT IS REPORTED THAT THERE WAS INJURY UNDER ONE OR MORE ELECTRODES AND ANOTHER USER STATED THAT SHE SMELLED SOMETHING BURNING AROUND THE UNIT AT THIS TIME, HOWEVER THERE IS NO REPORT OF BURN TO THE PATIENT. TREATING CLINICIAN REPORTS THAT THERE WAS NO MEDICAL INTERVENTION OR DELAY IN TREATMENT. DEVICE EVALUATION REPORTS THAT THERE WAS NO OUTPUT FOR CHANNEL 3. IT IS UNCLEAR IF THE CHANNEL 3 FAULT IS THE CAUSE OF THE REPORTED INJURY. DJO CONSIDERS ANY INCIDENT WITH EXTREME PAIN AS A REPORTABLE EVENT.